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Regulatory Affairs Senior Specialist (719182) at Zimmer Biomet CMF & Thoracic, LLC in Jacksonville, Florida

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:

Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. This position requires an advanced understanding of medical devices and their use as well as an understanding of the regulatory submissions process.

Principal Duties and Responsibilities

Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products Evaluates risk of proposed regulatory strategies and offers solutions Reviews proposed labeling for compliance with applicable US and international regulations Writes, manages, and approves the development of package inserts Reviews, evaluations, and approves promotion and advertising material for compliance with applicable regulations Reviews proposed product changes for impact on regulatory status of the product Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams Follows Zimmer Biomet regulatory affairs policy and procedures May provide training and/or guidance to entry-level associates, analysts, interns, and specialists Communicates with regulatory and governmental agencies Miscellaneous responsibilities as assigned

Expected Areas of Competence

• Demonstrated strong writing and communication skills • Strong interpersonal skills and attention to detail • Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities • Proficient knowledge of overall business environment, the orthopaedic industry and the marketplace • Mastery of relevant regulations pertinent to medical devices, biologics, drugs and combination products as applicable • Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization • Able to identify risk in regulatory strategies • Robust product knowledge • Advanced anatomic knowledge • Proven analytical and negotiation skills • Experience with solving problems and concerns • Intermediate computer skills, including Microsoft Office Suite • Ability to lead a team and influence others Proficient knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU

Education/Experience Requirements

• US Bachelor’s Degree (or non-US equivalent) required. Technical/engineering degree, life sciences or related field preferred. Alternate degrees may be considered. • Advanced degree preferred • A minimum of 5-7 years of experience in Regulatory Affairs, Engineering, Quality, or related field required • A minimum of 2 years of experience in orthopaedic or medical device industry preferred • Regulatory Affairs Certification (US or EU) preferred A combination of education, experience, leadership, strategy and RA influence may be considered

Travel Requirements

Up to 15%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. EOE M/F/Vet/Disability

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